Greetings and Welcome to the BiomX Third Quarter 2024 Financial Results Conference Call. At this time, all participants are in a listen-only mode. The question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce Marina Wolfson, Chief Financial Officer. Thank you. You may begin.
Thank you, and Welcome to the BiomX Conference Call to review the company's Q3 2024 financial results and provide an update on our business and programs. Later today, we will file the quarterly report on Form 10-Q with the Securities and Exchange Commission. In addition, the press release became available at 6:30 A.M. Eastern Time today and can be found on our website at biomx.com. A replay of this call will also be available on the Investors section of our website. As we begin, I'd like to review the safe harbor provision. All statements on this call that are not factual historic statements may be deemed forward-looking statements.
For instance, we're using forward-looking statements when we discuss on the conference call the sufficiency of the company's cash, our pipeline, the design, recruitment, aim, expected timing, and interim and final results of our preclinical and clinical trials, the potential benefits of our product candidates, and the potential safety or efficacy of our product candidates BX004 and BX211. In addition, past and current preclinical and clinical results, as well as compassionate use, are not indicative and do not guarantee future success of our clinical trials. Except as required by law, we do not undertake to update forward-looking statements. The full safe harbor provision, including risks that could cause actual results to differ from these forward-looking statements, are outlined in today's press release, which, as noted earlier, is on our website.
Joining me on the call this morning is BiomX Chief Executive Officer Jonathan Solomon, to whom I will now turn over the call.
Thank you, Marina. Good morning, everyone. Thank you for joining BiomX Quarterly Update. Throughout the last quarter, BiomX has focused on strategic execution and advancing our clinical pipeline. We are excited as we approach the landmark milestones in our diabetic foot osteomyelitis, or DFO, phase II trial of BX211. In the past quarter, we completed patient enrollment for the trial, and the readout for top-line results through week 13 is expected in the Q1 of 2025. We are grateful for the continued support behind the DFO program from the U.S. Defense Health Agency, or DHA, which provided additional funding this past quarter, bringing total non-dilutive funding received from the DHA towards this trial to $36.8 million to date. BX211 has the potential to dramatically transform treatment for patients suffering from DFO associated with Staphylococcus aureus. This is an area of high unmet need.
Each year, there is a staggering number of approximately 160,000 lower limb amputations in diabetic patients in the US alone, 85% of which are estimated to be caused by DFO, according to the current literature and the U.S. Centers for Disease Control. DFO is characterized by intractable infections that have penetrated the bone in patients with diabetic foot ulcers. Antibiotic therapy is the current standard of care but fails to treat 30%-40% of cases due to antibiotic resistance, accumulation of biofilm, and poor blood supply, limiting the concentration of IV and oral antibiotics to the site of infection. We believe that a phage-based therapeutic approach has the potential to greatly improve treatment outcomes in DFO. Phage's potential advantage stands in the ability to address challenges that antibiotics face, such as breakdown of biofilm and targeting antibiotic-resistant bacteria.
Reports in the scientific literature of compassionate use with phage therapy for the treatment of DFO associated with Staph aureus have shown that 11 of 12 cases resulted in positive outcomes of wound healing and avoiding amputations. Findings from these cases played an important role in the design of the ongoing phase II study of BX211. As a reminder, the phase II is a randomized double-blind placebo-controlled multi-center study investigating the safety, tolerability, and efficacy of BX211 in the standard of care antibiotics in subjects with DFO due to Staph aureus. Enrolled subjects are randomized at a two-to-one ratio to BX211 or placebo. BX211 or placebo are administered weekly by topical IV route at week one and by the topical route only at each of weeks 2-1 2.
Over a 12-week treatment period, all subjects are expected to continue to be treated in accordance with the standard of care, which will include antibiotic treatment as appropriate. The first readout of top-line results is expected at week 13, evaluating the healing of the wound associated with osteomyelitis. With respect to BX004, the company's novel fixed phage cocktail for the treatment of serious chronic lung infection in cystic fibrosis or CF patients caused by Pseudomonas aeruginosa, we are continuing preparation toward the phase II-B study. During the last quarter, the company has experienced manufacturing delays for BX004. The team has been working diligently to address these manufacturing challenges, which have been successfully resolved. However, as a result of these delays, we now expect to report top-line results for BX004 phase II-B study in the first half of 2026.
During the third quarter, we presented positive safety and efficacy results in BX004 phase I-B/2A trial at the North American Cystic Fibrosis Conference and the European Respiratory Society's annual meeting. Key highlights of the study presented, including that three out of 21 patients, which reflect 14.3%, converted to sputum culture negative for Pseudomonas aeruginosa after 10 days of treatment, including two patients after only four days in the BX004 arm, compared to 0% of the patients in the placebo arm. New data presented included that lung function is measured by forced expiratory volume in one second, or FEV1, increase in subjects receiving the cocktail compared to placebo. In the subgroup, on continuous inhaled antibiotics, meaning same antibiotic with no cycling or alternating regimen, on CFTR modulators and with lower lung functions, meaning FEV1 lower than 70%.
The scientific community's positive feedback to the data presented at these conferences has only further strengthened our confidence about the future of this program and its potential to address the unmet medical need of cystic fibrosis patients. Overall, we are confident about the promising data already reported and are looking forward to the Q1 of 2025, which will mark the next significant milestone for the company upon reporting top-line results for BX211 phase II trial in DFO. We believe our pipeline showcases the potential of phage therapy to address a wide range of antibiotic-resistant infections. I'll now pass you to Marina to review our third quarter financial results.
Thank you, Jonathan. As a reminder, the financial information for the company's Q3 2024 is available in the press release that we issued earlier today, as well as in more detail in our Form 10-Q, which we will file later today. I will now walk you through the highlights of our third quarter financial results. Cash balance, short-term deposits, and restricted cash as of 30 September 2024, were $24.7 million compared to $30.7 million as of 31 December 2023. The decrease was primarily due to net cash used in operating activities and the repayment of a Hercules debt facility, which was partially offset by the company's private placement financing of $50 million in March of 2024. We estimate that our cash, cash equivalents, and short-term deposits are sufficient to fund our operations into the Q4 of 2025.
Research and development expenses net were $7.3 million for the Q3 of 2024 compared to $5.6 million for the same period in 2023. The increase was primarily due to the following factors: preparations for the phase II-B trial of our CF product candidate, BX004, an increase in expenses relating to the clinical trial of our DFO product candidate, BX211, and an increase in rent-related expenses following our March acquisition of Adaptive Phage Therapeutics, or APT. This increase was partially offset by higher grants received. General and administrative expenses were $3.2 million for the Q3 of 2024 compared to $2.2 million for the same period in 2023. The increase is primarily attributed to a full quarter consolidation of expenses following APT's March acquisition, incorporating the combined workforce, increased professional services, and additional subcontractor expenses.
In the third quarter of 2024, we recognized goodwill impairment expenses of $801,000 resulting from the fair value assessment of goodwill related to the 2024 APT acquisition. No comparable goodwill impairment expenses were recorded in the same period of 2023. Net income was $9.6 million for the Q3 of 2024 compared to a net loss of $7.9 million for the same period in 2023. The increase primarily reflects non-cash income from the revaluation of warrants issued during the March 2024 financing. Net cash used in operating activities for the nine months ended 30 September 2024, was $30.7 million compared to $15 million for the same period in 2023. In August of 2024, we implemented a 1 to 10 reverse stock split. This consolidated our outstanding shares without affecting the par value of the common stock, nor the authorized number of shares of common stock or preferred stock.
Now I'll turn the call back over to Jonathan for his closing remarks. Jonathan?
Thanks, Marina. In conclusion, the last quarter was comprised of key events, including the finalization of patient enrollment for the BX211 phase II trial of DFO associated with Staphylococcus aureus, with a readout of top-line results expected in the Q1 of 2025. For BX004, we had the opportunity to present our promising clinical data at key scientific conferences during the Q3 and revise our phase II top-line readout timeline to the first half of 2026. We are confident in our phage pipeline's ability to address serious chronic infection and look forward to presenting some potentially life-changing data for DFO patients in the near future. Thank you all for your participation this morning.
Thank you. We'll now be conducting a question-and-answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two to remove yourself from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for your questions. Our first questions come from the line of Joseph Pantginis with H.C. Wainwright. Please proceed with your questions.
Hi, this is Sarah on for Joe. Thanks for taking the question. I was just wondering regarding the manufacturing delay you mentioned for BX004, if there's any additional details or specifics you're able to provide on the delay, and whether this was just a one-off extenuating circumstance or not, and thank you for taking the question.
Morning. And great question. So we do think and view it as a potentially one-off. One of the challenges that we had in gearing up for the larger phase II-B study is just larger volume. So far, we've manufactured 10 liters. This is like moving up to 50 liters. So there were some challenges in just calibrating all the system in the phage for 50 liters once that was set kind of back on track. So I think that's where we feel very confident with the process that we have and the revised timeline.
Okay. That's helpful. Thank you.
Thank you. I'm showing no further questions at this time. I'd like to hand the floor back over to Jonathan Solomon for closing remarks.
So thank you all again for participating. I wish you all happy holidays, and we look forward to updating you on the data and the upcoming DFO study. Thanks again.
Thank you. This does conclude today's teleconference. We appreciate your participation. You may disconnect your lines at this time. Enjoy the rest of your day.